Red-light therapy for patients with myopic maculopathy

JRCT ID: jRCTs032230061

Registered date:01/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: myopic maculopathy
• Date of first enrollment: 08/12/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Red light treatment is performed for 2 months us ing the research device Eyerising Myopia Manage ment Device. Red light therapy is phototherapy us ing low power red light at 650 nm. Subjects will be treated with a therapy device twice a day from Monday to Saturday, three minutes per
session, with a minimum interval of 4 hours, under the supervision of their parents.

Outcome(s)

• Primary Outcome: Incidence rate of choroidal thickening greater than 5 percentage compared to baseline at 2-month follow-up.

Secondary Outcome

(1) Incidence rate of choroidal thickening greater than 10 percentage compared to baseline at 2-month follow-up.
(2) Changes of choriocapillaris flow deficit, choroidal vascularity index, choroidal thickness assessed by ultrawide-field/widefield OCT scan at 1-, 3-, 6- and 12-month follow-up visits compared with those at baseline.
(3) Best corrected visual acuity, OCT structural changes on neurosensory layer, RPE and choroidal layer, selfreported AE.
(4) Changes in AL and other biometric parameters at 2-month follow-up.
(5) Change in SER at 2-month follow-up.
(6) Change of META-PM grading at 2-month follow-up.
(7) Report of adverse events by questionnaire and
interview/examination at the time of visit.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Provision of consent.
(2) Age. 18 years or older.
(3) Patients with either peripapillary diffuse atrophy
(PDCA) or macular diffuse choroidal atrophy (MDCA), which are early findings of myopic maculopathy, in both or one eye on color fundus photographs.Posterior staphyloma with or without.
(4) High myopia. sphere is less than -6.00D.
(5) Patients with a central foveal choroidal thickness(SFCT) of 50um or greater in eyes with early findings of myopic maculopathy.
(6) Willing and able to participate in all required of the study.

Exclude criteria

(1) Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, o r syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
(2) Patients with retinitis pigmentosa-related diseases or other retinal hereditary diseases in the family.
(3) Patients with night blindness.
(4) Strabismus and binocular vision abnormalities in either eye.
(5) Previous any intraocular surgery affecting refractive status.
(6) Patients who have received low-dose atropine eye drops, orthokeratology, or progressive multifocal frame myopia progression control treatment in the past year.
(7) Patients with myopic maculopathy plus lesions (myopic choroidal neovascularization, Fuchs spots, Lc).
(8) Patients with systemic diseases (cardiac, respiratory, etc.).
(9) Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

Related Information

• Primary Sponsor: Ohno Kyoko
• Source(s) of Monetary Support: Eye-Lens Pte Ltd